510(k) Report

510(k) · Cleared

Cleared

Wizair DVT

K012994510(k) TraditionalCleared Mar 27, 2002202-day reviewClass II21 CFR 870.5800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medical Compression Systems (Dbn), Ltd. · JOW Sleeve, Limb, Compressible

Cleared on Mar 27, 2002 after a 202-day review. The FDA summary names no predicate by number. 36 later devices descend from it.

Decided
Mar 27, 2002
Review
202 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
0

36 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2006: 4 descendants cleared2008: 2 descendants cleared2012: 3 descendants cleared2010: 1 descendant cleared2011: 2 descendants cleared2018: 1 descendant cleared2013: 1 descendant cleared2016: 2 descendants cleared2024: 3 descendants cleared2020: 3 descendants cleared2021: 4 descendants cleared2014: 2 descendants cleared2019: 1 descendant cleared2017: 2 descendants cleared2015: 1 descendant cleared2023: 2 descendants cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK012994 Wizair DVTMedical Compression Systems (Dbn), Ltd. · 2002
  2. Descendant · cites it directly · 30 of its ownK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
  3. Descendant · 2 generations on · 10 of its ownK062818 Flexitouch SystemTactile Systems Technology, Inc. · 2006
  4. Descendant · 3 generations on · 9 of its ownK120972 Flexitouch SystemTactile Systems Technology, Inc. · 2012
  5. Descendant · 2 generations on · 9 of its ownK110159 Activecare SFTMedical Compression Systems (Dbn), Ltd. · 2011
  6. Descendant · 3 generations on · 8 of its ownK153311 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2016

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2005: 12006: 42008: 22010: 12011: 22012: 32013: 12014: 22015: 12016: 22017: 22018: 12019: 12020: 32021: 42023: 22024: 32026: 1
2005high 4 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 36 · See all
  • K060146Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · cites it directly30descendants
  • K062818Flexitouch SystemTactile Systems Technology, Inc. · 2006 · 2 generations on10descendants
  • K120972Flexitouch SystemTactile Systems Technology, Inc. · 2012 · 3 generations on9descendants
  • K110159Activecare SFTMedical Compression Systems (Dbn), Ltd. · 2011 · 2 generations on9descendants
  • K153311Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2016 · 3 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K012994Wizair DVTMedical Compression Systems (Dbn), Ltd.2002—
+1K060146Activecare ++ SystemMedical Compression Systems (Dbn), Ltd.20061
+2K062818Flexitouch SystemTactile Systems Technology, Inc.2006—
+3K120972Flexitouch SystemTactile Systems Technology, Inc.2012—
+2K110159Activecare SFTMedical Compression Systems (Dbn), Ltd.2011—
+3K153311Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical)2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200640
200820
201010
201120
201230
201310
201420
201510
201620
201720
201810
201910
202030
202140
202320
202430
202610
FIG. 1 — Lineage of K012994, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JOW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JOW device

  1. #1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (36)

See all 36

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K060146Activecare ++ SystemMedical Compression Systems (Dbn), Ltd.200630
K122609Vasculaire Compression System Model FLS-0003; Vasculaire Sleeve (Foot & Calf) Model…Venous Health Systems, Inc.20123
K051438Vanguard Reprocessed Compression Garments (Hill-Rom)Alliance Medical, Inc.20061
K053316Reprocessed Compression SleevesAlliance Medical Corp.20061
K071763Amadeus Adaptive Compression TherapyConvatec20080
K042217Flowmedic, Model 220Flowmedic (Israel), Ltd.20050

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K060146 (Medical Compression Systems (Dbn), Ltd., 2006) has gone furthest, with 30 descendants of its own.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOW

7in 2025

2007: 62008: 42009: 32010: 182011: 112012: 132013: 172014: 162015: 102016: 92017: 92018: 112019: 112020: 142021: 162022: 72023: 62024: 82025: 72026 (partial year): 6
2007high 18 (2010) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOW

168in 2025

2007: 66 days median2008: 112 days median2009: 84 days median2010: 71 days median2011: 104 days median2012: 63 days median2013: 94 days median2014: 91 days median2015: 160 days median2016: 121 days median2017: 116 days median2018: 136 days median2019: 88 days median2020: 158 days median2021: 132 days median2022: 80 days median2023: 160 days median2024: 197 days median2025: 168 days median2026 (partial year): 252 days median
2007high 252 (2026) · low 63 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JOW

1in 2019

2008: 72010: 22011: 32012: 22017: 12019: 1
2007high 7 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JOW

24in 2025

2007: 122008: 362009: 452010: 662011: 502012: 1002013: 1692014: 932015: 1372016: 1502017: 1492018: 1142019: 1022020: 502021: 342022: 272023: 572024: 302025: 24
2007high 169 (2013) · low 12 (2007)2025

MAUDE reports naming product code JOW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007666012
20084112736
2009384045
20101871266
201111104350
201213632100
201317940169
20141691093
2015101600137
201691210150
201791161149
2018111360114
201911881102
202014158050
202116132034
2022780027
20236160057
20248197030
20257168024
202662520—

What is it indicated for?

The WizAir DVT™ is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.

The WizAir DVT™ is intended for use in:

Preventing Deep Vein Thrombosis (DVT).

Enhancing blood circulation.

Diminishing post-operative pain and swelling.

Reducing wound-healing time.

Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers.

Treatment of chronic venous insufficiency.

Reducing edema.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Medical Compression Systems (Dbn), Ltd.

10 FDA decisions under this applicant name. See the company

  • K160431ActiveCare HomeMedical Compression Systems (Dbn), Ltd. · 2016
  • K140755Activecare DVT, Activecare+SFT, and Activecare+DTX SystemsMedical Compression Systems (Dbn), Ltd. · 2014
  • K113525Activecare DVT Activecare+SFTMedical Compression Systems (Dbn), Ltd. · 2012
  • K110159Activecare SFTMedical Compression Systems (Dbn), Ltd. · 2011
  • K060146Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 20061 recall

Recent decisions in JOW

The JOW category page

  • K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc. · 2026
  • K254217AerloomEvolym, LLC · 2026
  • K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical · 2026
  • K253386DVT GarmentVistar Medical Supplies Co., Ltd. · 2026
  • K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd. · 2026

https://510kreport.com/device/K012994 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012994: Wizair DVT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012994

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026